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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Sorafenib
Generic Name
Sorafenib
Active Ingredient
SorafenibCategory
Kinase Inhibitor [EPC]
Variants
6
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Sorafenib, you must consult a qualified healthcare professional.
| 200 mg/1 | TABLET, FILM COATED | ORAL | 0480-5425 |
| 200 mg/1 | TABLET, FILM COATED | ORAL | 13668-682 |
| 200 mg/1 | TABLET, FILM COATED | ORAL | 24979-715 |
Detailed information about Sorafenib
Sorafenib is a potent multi-kinase inhibitor (TKI) used to treat advanced hepatocellular carcinoma, renal cell carcinoma, and differentiated thyroid carcinoma by targeting tumor cell proliferation and blood supply.
The standard recommended adult dosage for Sorafenib, regardless of the indication (HCC, RCC, or DTC), is 400 mg (two 200 mg tablets) taken twice daily. This results in a total daily dose of 800 mg.
Treatment is typically continued as long as the patient is deriving clinical benefit or until unacceptable toxicity occurs. Your oncologist may modify this dose based on your individual tolerance. For example, if you experience significant skin toxicity or high blood pressure, your doctor may reduce the dose to 400 mg once daily, or 400 mg every other day, or temporarily interrupt treatment.
The safety and effectiveness of Sorafenib in pediatric patients (children under 18 years of age) have not been established. Clinical trials in children are limited, and Sorafenib is not currently FDA-approved for use in the pediatric population. Healthcare providers generally avoid prescribing it to children unless part of a specific clinical trial.
No dosage adjustment is required for patients with mild to moderate renal impairment (CrCl > 30 mL/min). However, Sorafenib has not been extensively studied in patients with severe renal impairment or those requiring hemodialysis. In these cases, close monitoring for adverse effects is essential.
For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, no initial dose adjustment is typically necessary. However, Sorafenib has not been studied in patients with severe hepatic impairment (Child-Pugh C). Since the drug is primarily metabolized in the liver, patients with severe liver dysfunction may experience increased drug levels and higher toxicity risks.
In clinical trials, no overall differences in safety or efficacy were observed between patients over 65 and younger patients. However, because older adults are more likely to have decreased organ function and concurrent medications, doctors often monitor them more closely for side effects like hypertension or fatigue.
To ensure maximum effectiveness and safety, follow these specific administration guidelines:
If you miss a dose of Sorafenib, skip the missed dose and take your next dose at the regularly scheduled time. Do not 'double up' or take two doses at once to make up for a missed one. If you vomit after taking a dose, do not take an additional tablet; simply wait until your next scheduled dose.
Signs of Sorafenib overdose may include an intensification of common side effects, such as severe diarrhea or severe skin reactions (Hand-Foot Skin Reaction). If an overdose is suspected, contact your local poison control center or seek emergency medical attention immediately. There is no specific antidote for Sorafenib overdose; treatment is supportive.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop the medication without first consulting your medical team.
Sorafenib is associated with a high frequency of side effects, many of which are related to its mechanism of inhibiting blood vessel growth and skin cell signaling. According to clinical trial data (2024), the following are most common:
Sorafenib is a potent medication that requires careful monitoring by an oncology specialist. Patients must be aware that this drug affects multiple systems in the body, particularly the cardiovascular system and the skin. Before starting Sorafenib, you must disclose your full medical history, especially any history of heart disease, high blood pressure, or bleeding disorders.
No FDA black box warnings for Sorafenib. However, the absence of a boxed warning does not imply the drug is without risk; the 'Warnings and Precautions' section of the label contains critical information regarding life-threatening risks like GI perforation and cardiac events.
There are specific circumstances where Sorafenib must NEVER be used because the risks far outweigh any potential benefits:
These are conditions where the doctor must perform a careful risk-benefit analysis before prescribing:
Sorafenib is considered highly dangerous to a developing fetus. Based on its mechanism of action (inhibiting angiogenesis and cell growth), it can cause fetal harm, including structural abnormalities and fetal death.
It is not known whether Sorafenib or its metabolites are excreted in human milk. However, because of the potential for serious adverse reactions in a nursing infant (including growth suppression and organ toxicity), women are advised
Sorafenib is a small-molecule inhibitor of multiple intracellular and cell surface kinases. It specifically targets:
The pharmacodynamic effect of Sorafenib is dose-dependent. Studies have shown that higher plasma concentrations correlate with greater inhibition of the ERK phosphorylation in tumor tissue. However, the dose-response relationship is also tied to toxicity, particularly Hand-Foot Skin Reaction and hypertension. There is no evidence of tolerance development; the drug remains effective as long as the signaling pathways remain sensitive to the inhibitor.
Common questions about Sorafenib
Sorafenib is a targeted therapy medication used primarily to treat three specific types of advanced cancer: hepatocellular carcinoma (liver cancer), renal cell carcinoma (kidney cancer), and differentiated thyroid carcinoma. It is typically prescribed when these cancers have spread to other parts of the body or cannot be removed by surgery. Unlike traditional chemotherapy, Sorafenib works by blocking specific proteins that tell cancer cells to grow and by preventing the formation of new blood vessels that feed the tumor. It is often a first-line systemic treatment for liver cancer patients who have preserved liver function. Your doctor will determine if this is the best option based on your specific cancer stage and overall health.
The most frequently reported side effects of Sorafenib include Hand-Foot Skin Reaction (redness, pain, or blisters on the palms and soles), diarrhea, fatigue, and high blood pressure. Many patients also experience thinning hair (alopecia), weight loss, and a decreased appetite. These side effects often appear within the first few weeks of starting the medication. While some are mild, others like severe diarrhea or skin reactions may require a dose reduction or temporary pause in treatment. It is crucial to monitor your blood pressure regularly and report any skin changes to your oncology team immediately for management.
There is no known direct chemical interaction between alcohol and Sorafenib, but most healthcare providers recommend avoiding or strictly limiting alcohol consumption during treatment. Alcohol can cause dehydration and put extra stress on the liver, which is already working hard to metabolize the medication. Furthermore, alcohol can worsen certain side effects of Sorafenib, such as diarrhea and fatigue. If you have liver cancer (HCC), your liver function may already be compromised, making alcohol consumption particularly risky. Always discuss your lifestyle habits, including alcohol use, with your oncologist to ensure the safest treatment environment.
No, Sorafenib is not safe to take during pregnancy and is known to cause significant harm to a developing fetus. Because the drug works by stopping the growth of new blood vessels and cells, it can lead to severe birth defects or pregnancy loss. Women of childbearing age must have a negative pregnancy test before starting the drug and use highly effective birth control throughout treatment and for six months after the last dose. Men taking Sorafenib should also use contraception if their partner could become pregnant. If you become pregnant while taking this medication, you must notify your doctor immediately.
Sorafenib begins working at the molecular level shortly after you start taking it, but it may take several weeks or even months to see a measurable change in tumor size or disease progression on a scan. In many cases, the goal of Sorafenib is 'stable disease,' meaning the cancer stops growing rather than shrinking significantly. Doctors typically perform imaging tests (like CT or MRI scans) every 8 to 12 weeks to evaluate how well the drug is working. You may notice improvements in cancer-related symptoms, but the primary evidence of success is the slowing of the disease's progression over time.
You should never stop taking Sorafenib suddenly without first discussing it with your healthcare provider. Stopping the medication can allow the cancer to begin growing or spreading again more rapidly. If you are experiencing severe side effects, your doctor may suggest a 'dose holiday' or a lower dose rather than stopping the drug entirely. If discontinuation is necessary due to toxicity or because the drug is no longer working, your oncologist will manage the transition to a different therapy. Always follow the specific medical guidance provided by your oncology team regarding the duration of your treatment.
If you miss a dose of Sorafenib, you should skip the missed dose and simply take your next scheduled dose at the usual time. Do not take two doses at once to make up for the one you missed, as this can increase the risk of dangerous side effects like severe high blood pressure or skin reactions. If you frequently forget your doses, consider using a pill organizer or setting an alarm on your phone. Consistency is key to keeping the drug at an effective level in your body. If you miss more than one dose in a row, contact your doctor for further instructions.
No, Sorafenib is much more likely to cause weight loss rather than weight gain. Weight loss is a very common side effect and is often linked to a decreased appetite (anorexia), changes in taste, or persistent diarrhea. In clinical trials, a significant percentage of patients experienced some degree of weight reduction. If you notice rapid or severe weight loss, it is important to speak with a dietitian or your doctor, as they may recommend nutritional supplements or medications to help manage your appetite. In rare cases, swelling (edema) might cause a slight increase in weight, but this should be evaluated by a doctor immediately.
Sorafenib has several significant drug interactions, so it must be used cautiously with other medications. It can interact with blood thinners like warfarin, increasing the risk of bleeding, and with certain antibiotics like neomycin. It also interacts with drugs processed by the CYP3A4 enzyme, such as rifampin or St. John's Wort, which can make Sorafenib less effective. Always provide your doctor and pharmacist with a complete list of all prescription drugs, over-the-counter medicines, vitamins, and herbal supplements you are taking. This allows your medical team to check for safety and adjust your treatment plan if necessary.
Yes, Sorafenib is available as a generic medication in many countries, including the United States. The generic version contains the same active ingredient and meets the same FDA standards for quality and effectiveness as the brand-name version, Nexavar. Generic Sorafenib is typically more affordable than the brand-name drug, which can be a significant factor for long-term cancer treatment. When your doctor prescribes Sorafenib, you can ask if a generic version is available at your pharmacy. Both the brand and generic versions are 200 mg tablets and are taken in the same manner.
Other drugs with the same active ingredient (Sorafenib)
> Warning: Stop taking Sorafenib and call your doctor immediately if you experience any of these symptoms.
Prolonged use of Sorafenib may lead to chronic issues such as persistent hypothyroidism, which requires lifelong thyroid hormone replacement. There is also a risk of developing permanent changes in skin texture or chronic fatigue. Regular monitoring of organ function is vital for patients on long-term therapy.
As of 2026, there are no FDA black box warnings for Sorafenib. However, the FDA provides 'Warnings and Precautions' regarding cardiac ischemia, hemorrhage, hypertension, and Hand-Foot Skin Reaction, which are considered significant safety concerns that require strict clinical oversight.
Report any unusual symptoms or changes in your health to your healthcare provider immediately. Early intervention can often prevent side effects from becoming severe enough to require stopping the medication.
To ensure safety, your healthcare team will require regular testing:
There is no evidence that Sorafenib directly impairs the ability to drive. However, side effects like fatigue, dizziness, or confusion (rare) can occur. You should assess how the medication affects you before operating heavy machinery or driving.
While there is no direct contraindication for alcohol, it is generally advised to limit alcohol consumption while taking Sorafenib. Alcohol can strain the liver, which is already processing the medication, and may worsen side effects like diarrhea or dehydration.
Do not stop taking Sorafenib suddenly without consulting your oncologist. While there is no 'withdrawal syndrome' like that seen with some psychiatric drugs, stopping the drug can lead to rapid progression of the underlying cancer. If you must stop due to side effects, your doctor will provide a specific plan for re-starting or switching therapies.
> Important: Discuss all your medical conditions, including any planned surgeries or dental procedures, with your healthcare provider before starting Sorafenib.
Sorafenib does not typically cause false positives on standard drug screens. However, it can significantly alter clinical lab results, including:
For each major interaction, the mechanism usually involves the Cytochrome P450 system or the UGT conjugation pathway. Management typically involves dose adjustment, more frequent monitoring, or selecting alternative medications.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter pain relievers and vitamins.
While there is no definitive cross-sensitivity list, patients who have had severe reactions to other VEGFR-targeting TKIs (like sunitinib or pazopanib) should be monitored with extra care, as they may share similar metabolic pathways or trigger similar immune responses.
> Important: Your healthcare provider will evaluate your complete medical history, including any underlying heart or liver conditions, before deciding if Sorafenib is safe for you.
As previously mentioned, Sorafenib is not approved for use in children. There are concerns regarding the drug's effect on growing bones and organs. In animal studies, Sorafenib caused changes in the growth plates and teeth. If used off-label in a child, growth and development must be monitored with extreme precision.
Clinical data suggest that patients over 65 do not require a specific dose adjustment. However, elderly patients are at a higher risk for cardiovascular side effects (like heart failure or hypertension) and may be more susceptible to the dehydrating effects of diarrhea. Polypharmacy (taking many medications) is common in the elderly, increasing the risk of drug-drug interactions.
> Important: Special populations require individualized medical assessment and more frequent laboratory monitoring.
| Parameter | Value |
|---|---|
| Bioavailability | 38% - 49% (Reduced by high-fat food) |
| Protein Binding | 99.5% (Primarily Albumin) |
| Half-life | 25 - 48 hours |
| Tmax | ~3 hours |
| Metabolism | Hepatic (CYP3A4 and UGT1A9) |
| Excretion | Fecal 77%, Renal 19% |
Sorafenib is classified as a Multi-Kinase Inhibitor [EPC] and a Tyrosine Kinase Inhibitor (TKI). It is related to other TKIs like Sunitinib and Lenvatinib but has a unique binding profile that makes it particularly effective in hepatocellular carcinoma.